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Epicardial delivery of autologous atrial appendage micrografts during coronary artery bypass surgery-safety and feasibility study.

ABSTRACT: Background:The atrial appendages are a tissue reservoir for cardiac stem cells. During on-pump coronary artery bypass graft (CABG) surgery, part of the right atrial appendage can be excised upon insertion of the right atrial cannula of the heart-lung machine. In the operating room, the removed tissue can be easily cut into micrografts for transplantation. This trial aims to assess the safety and feasibility of epicardial transplantation of atrial appendage micrografts in patients undergoing CABG surgery. Methods/design:Autologous cardiac micrografts are made from leftover right atrial appendage during CABG of 6 patients. Atrial appendage is mechanically processed to micrografts consisting of atrial appendage-derived cells (AADCs) and their extracellular matrix (ECM). The micrografts are epicardially transplanted in a fibrin gel and covered with a tissue-engineered ECM sheet. Parameters including echocardiography-reflecting cardiac insufficiency-are studied pre- and post-operatively as well as at 3 and 6 months of the follow-up. Cardiac functional magnetic resonance imaging is performed preoperatively and at 6-month follow-up. The primary outcome measures are patient safety in terms of hemodynamic and cardiac function over time and feasibility of therapy administration in a clinical setting. Secondary outcome measures are left ventricular wall thickness, change in the amount of myocardial scar tissue, changes in left ventricular ejection fraction, plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, New York Heart Association class, days in hospital, and changes in the quality of life. Twenty patients undergoing routine CAGB surgery will be recruited to serve as a control group. Discussion:This study aims to address the surgical feasibility and patient safety of epicardially delivered atrial appendage micrografts during CABG surgery. Delivery of autologous micrografts and AADCs has potential applications for cell and cell-based gene therapies. Trial registration:ClinicalTrials.gov Identifier: NCT02672163. Date of registration: 02.02.2016.

SUBMITTER: Nummi A

PROVIDER: S-EPMC5738681 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Epicardial delivery of autologous atrial appendage micrografts during coronary artery bypass surgery-safety and feasibility study.

Nummi Annu A Nieminen Tuomo T Pätilä Tommi T Lampinen Milla M Lehtinen Miia L ML Kivistö Sari S Holmström Miia M Wilkman Erika E Teittinen Kari K Laine Mika M Sinisalo Juha J Kupari Markku M Kankuri Esko E Juvonen Tatu T Vento Antti A Suojaranta Raili R Harjula Ari A

Pilot and feasibility studies 20171220

<h4>Background</h4>The atrial appendages are a tissue reservoir for cardiac stem cells. During on-pump coronary artery bypass graft (CABG) surgery, part of the right atrial appendage can be excised upon insertion of the right atrial cannula of the heart-lung machine. In the operating room, the removed tissue can be easily cut into micrografts for transplantation. This trial aims to assess the safety and feasibility of epicardial transplantation of atrial appendage micrografts in patients undergo ...[more]

PMID: 29276625

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Project description:Background: Cardio-regenerative cell therapies offer additional biologic support to coronary artery bypass surgery (CABG) and are aimed at functionally repairing the myocardium that suffers from or is damaged by ischemia. This non-randomized open-label study assessed the safety and feasibility of epicardial transplantation of atrial appendage micrografts (AAMs) in patients undergoing CABG surgery. Methods: Twelve consecutive patients destined for CABG surgery were included in the study. Six patients received AAMs during their operation and six patients were CABG-operated without AAMs transplantation. Data from 30 elective CABG patients was collected for a center- and time-matched control group. The AAMs were processed during the operation from a biopsy collected from the right atrial appendage. They were delivered epicardially onto the infarct scar site identified in preoperative late gadolinium enhancement cardiac magnetic resonance imaging (CMRI). The primary outcome measures at the 6-month follow-up were (i) patient safety in terms of hemodynamic and cardiac function over time and (ii) feasibility of therapy administration in a clinical setting. Secondary outcome measures were left ventricular wall thickness, change in myocardial scar tissue volume, changes in left ventricular ejection fraction, plasma concentrations of N-terminal pro-B-type natriuretic peptide levels, NYHA class, number of days in hospital and changes in the quality of life. Results: Epicardial transplantation of AAMs was safe and feasible to be performed during CABG surgery. CMRI demonstrated an increase in viable cardiac tissue at the infarct site in patients receiving AAMs treatment. Conclusions and Relevance: Transplantation of AAMs shows good clinical applicability as performed during cardiac surgery, shows initial therapeutic effect on the myocardium and has the potential to serve as a delivery platform for cardiac gene therapies. Trial Registration:ClinicalTrials.gov, identifier: NCT02672163.

Project description:BACKGROUND:Widespread use of intraoperative epicardial ultrasonography (ECUS) for quality assessment of coronary artery bypass graft anastomoses during coronary artery bypass grafting (CABG) has not occurred - presumably due to technological and practical challenges including the need to maintain stable and optimal acoustic contact between the ultrasound probe and the target without the risk of distorting the anastomosis. We investigated the feasibility of using a stabilizing device during ultrasound imaging of distal coronary bypass graft anastomoses in patients undergoing on-pump CABG. Imaging was performed in both the longitudinal and transverse planes. METHODS:Single-centre, observational prospective feasibility study among 51 patients undergoing elective, isolated on-pump CABG. Ultrasonography of peripheral coronary bypass anastomoses was performed using a stabilizing device upon which the ultrasound transducer was connected. Transit-time flow measurement (TTFM) was also performed. Descriptive statistical tests were used. RESULTS:Longitudinal and transverse images from the heel, middle and toe were obtained from 134 of 155 coronary anastomoses (86.5%). After the learning curve (15 patients), all six projections were obtained from 100 of 108 anastomoses scanned (93%). Failure to obtain images were typical due to a sequential curved graft with anastomoses that could not be contained in the straight cavity of the stabilizing device, echo artefacts from a Titanium clip located in the roof of the anastomoses, and challenges in interpreting the images during the learning curve. No complications were associated with the ECUS procedure. The combined ECUS and TTFM resulted in immediate revision of five peripheral anastomoses. CONCLUSIONS:Peroperative use of a stabilizing device during ultrasonography of coronary artery bypass anastomoses in on-pump surgery facilitates imaging and provides surgeons with non-deformed longitudinal and transverse images of all parts of the anastomoses in all coronary territories. Peroperative ECUS in addition to flow measurements has the potential to increase the likelihood of detecting technical errors in constructed anastomoses. TRIAL REGISTRATION:The study was registered on September 29, 2016, ClinicalTrials.gov ID: NCT02919124.

Dataset Information

Epicardial delivery of autologous atrial appendage micrografts during coronary artery bypass surgery-safety and feasibility study.

Publications

Epicardial delivery of autologous atrial appendage micrografts during coronary artery bypass surgery-safety and feasibility study.

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